You can learn the key points for creating and revising GMP documents as stipulated by the 2021 revised GMP ministerial ordinance.
〇Concept of Quality Manual and Pharmaceutical Quality System (PQS) 〇As for GMP-related documents such as "Hygiene Management Procedure," "Manufacturing Management Procedure," "Quality Control Procedure," "Stability Monitoring Procedure," "Procedure for Quality Verification," "Validation Procedure," etc., an explanation including the underlying concepts will be provided. ☆An explanation will also be given regarding shipment management, management of raw material suppliers and external contractors, and related documents. 〇An overview of the Pharmaceutical Quality System (PQS) that should be understood when writing the Quality Manual will be explained. 〇A detailed explanation of the items included in the "Quality Manual" and important items such as "Management Review," "Quality Policy," "Quality Objectives/Quality Plan," etc. 〇An overview of the key performance indicators (KPI) for evaluating the achievement of quality objectives mentioned in the GMP case studies will be explained.
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basic information
- Publication: Scheduled for the end of December 2022 - Format: B5 size, approximately 160 pages - Price: ¥40,700 (including tax at 10%) - ISBN: 978-4-86502-241-4 - Author: Hajime Takagi [Brief Biography] At Shionogi & Co., Ltd., he has carried out a wide range of tasks from formulation development to factory operations, including the industrialization of oral medications and freeze-dried injectables, providing technical guidance to domestic and overseas affiliated companies, and serving as the manufacturing management responsible for the sterile preparation building.
Price information
List price: 40,700 yen (including tax (10% consumption tax))
Price range
P2
Delivery Time
※If you would like a delivery date in mid-December 2023, please contact us.
Applications/Examples of results
Chapter 1: Quality Manual Chapter 2: Hygiene Management Procedures, Manufacturing Management Procedures, Quality Management Procedures Chapter 3: Procedures for Stability Monitoring Chapter 4: Procedures for Product Quality Verification Chapter 5: Procedures for Managing Suppliers of Raw Materials, etc. Chapter 6: Procedures for Managing External Contractors Chapter 7: Procedures for Managing Shipments from Manufacturing Sites Chapter 8: Procedures for Validation (Validation Master Plan) Chapter 9: Procedures for Change Management Chapter 10: Procedures for Deviation Management Chapter 11: Procedures for Handling Quality Information and Quality Defects, etc. Chapter 12: Procedures for Handling Recalls, etc. Chapter 13: Procedures for Self-Inspection Chapter 14: Procedures for Education and Training Chapter 15: Procedures for Creating, Revising, and Storing Documents and Records Chapter 16: SOP and Manufacturing Instruction Records
Company information
The information organization aims to contribute to the development of the industry through technical seminars on chemistry, pharmaceuticals, electronics, machinery, environment, cosmetics, food, etc., as well as the publication of technical books, correspondence courses, and DVDs that record seminars.
